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Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03583216
Enrollment
60
Registered
2018-07-11
Start date
2018-07-20
Completion date
2018-11-30
Last updated
2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complement System; Disorder, Diabetic Pregnancy, Pregnancy Related

Keywords

Diabetic pregnancies, Factor XII

Brief summary

To compare Factor XII levels in gestational diabetic and healthy pregnancies.

Detailed description

Thirty singleton term pregnant women with a diagnosis of Type I, Type II or gestational diabetes and thirty singleton uncomplicated term healthy pregnant women will be included in our study. Our study will be performed at Istanbul Acibadem Maslak Hospital, Turkey. Blood will be drawn from each patient when they are hospitalized and before they deliver either vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will contain 4 ml blood. Blood will be transferred to the lab immediately and will be centrifuged. The supernatant will be stored at -80°C. When the anticipated number of samples are completed Factor XII levels will be calculated in each sample.

Interventions

DIAGNOSTIC_TESTDiabetic pregnancy

Blood samples will be drawn before delivery to evaluate Factor XII level.

DIAGNOSTIC_TESTNon-diabetic pregnancy

Blood samples will be drawn before delivery to evaluate Factor XII level.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Term pregnancy * Pregnant patients with a diagnosis of Type I diabetes * Pregnant patients with a diagnosis of Type II diabetes * Pregnant patients with a diagnosis of Gestational diabetes * Non-diabetic pregnancies * Uncomplicated pregnancies

Exclusion criteria

* Preterm pregnancy * Postterm pregnancy * Pregnant patients with a diagnosis of systemic diseases other than diabetes * Complicated pregnancies

Design outcomes

Primary

MeasureTime frameDescription
Factor XII levelBlood will be drawn when the patient is hospitalized before they deliver.The primary outcome is to evaluate Factor XII level in diabetic pregnancies. If the investigators can prove that Factor XII, which has a mitogenic activity and can increase the risk for thrombosis, increases more in diabetic pregnancies in the future usage of Factor inhibitors may reduce macrosomia, thrombosis and the complications due to these conditions in diabetic pregnancies

Secondary

MeasureTime frameDescription
MacrosmiaBlood will be drawn when the patient is hospitalized before they deliver.The secondary outcome is to prove that the increase of Factor XII level is higher diabetic pregnancies and this increase might have an effect on macrosomia.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026